Hikma extends license agreement with Celltrion for Remsima subcutaneous formulation in MENA region


London, UK (AETOSWire): Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces an exclusive licensing agreement with South Korea-based Celltrion, Inc. and Celltrion Healthcare, Inc. (Celltrion) for Remsima® subcutaneous (SC), the first subcutaneous formulation of infliximab.

Agreement grants Hikma exclusive rights to market Remsima® SC, the world’s first subcutaneous formulation of infliximab, in all of its MENA markets. It builds on the existing partnership between Hikma and Celltrion for three of its biosimilar products, Truxima® (rituximab), Remsima® (infliximab) and Herzuma® (trastuzumab). Remsima® SC is used in the treatment of rheumatoid arthritis and a number of other conditions.

“We are delighted to build on the success of our long-term agreement with Celltrion and add Remsima® to our portfolio of biosimilar products in the MENA region,” said Mazen Darwazah, Executive Vice President of Hikma and President of the MENA Region. “Subcutaneous administration has been shown to be effective, safe, well tolerated and generally preferred by patients. This new formulation allows administration outside the hospital setting, allowing a greater number of patients to access the treatment. This is another example of Hikma using its capabilities to increase access to important medicines and introduce delivery systems that can improve the quality of life for patients as part of our mission to bring better health. at your fingertips, every day.


About Remsima® (CT-P13) intravenous (IV) formulation

Remsima® IV is usually given at 3 mg per kg/body weight in rheumatoid arthritis (RA) and 5 mg per kg/body weight for other indications. Infliximab IV is given as a two-hour infusion. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.

About Remsima® Subcutaneous (SC) CT-P13 Formulation

A fixed dose of 120 mg of Remsima® SC has obtained marketing authorization in the EU, in adults, regardless of body weight, in all previously approved indications for the IV formulation. Remsima® SC has three administration options; via a pre-filled pen (auto-injector), pre-filled syringe or pre-filled syringe with needle shield. CT-P13 SC is currently approved in 41 countries and marketed in 13 countries. It is approved for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis, and rheumatoid arthritis.

*Source: AETOWire

Hikma Pharmaceuticals PLC
Dana Alhusseini, Communications Manager
[email protected]

© Press release 2022


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